A Phase 2 interventional study of Finerenone (BAY 94-8862) and Semaglutide 14 MG [Rybelsus] in Chronic Kidney Disease, sponsored by University Medical Center Groningen. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University Medical Center Groningen · Phase 2, Interventional, and Treatment
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Among 25 studies testing finerenone in Renal Insufficiency, Chronic — 14 open to participants now, 16 under way, 4 of them phase 3. finerenone · Renal Insufficiency, Chronic.
Among the 25 studies testing finerenone in Renal Insufficiency, Chronic, this one is the 20th largest by enrollment, is one of 4 that started in 2025, is one of 4 in phase 2, and was the 24th registered.
3,095 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →14 of the 25 studies testing finerenone in Renal Insufficiency, Chronic are open now, in 12 countries. Recruiting first, the newest first:
Peter Rossing · Sites in Denmark, Germany, Spain and 1 more country
Ages 18–75
Chinese University of Hong Kong · Sites in Hong Kong
Ages 18+
University of Aarhus · Sites in Denmark
Ages 18+
The George Institute · Sites in Australia, India, New Zealand and 2 more countries
Ages 18+
Bayer · Sites in United States, Argentina, Australia and 29 more countries
Ages 1–18
By country, each count listing its studies:
finerenone: first FDA approval 2021 (KERENDIA), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 73 across 2,162 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 100 across the 25 interventional studies. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 25 have an industry lead sponsor. The 10 most frequent:
University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 175 are open to participants now.
14 studies in Renal Insufficiency, Chronic by University Medical Center Groningen: 5 open now, 6 under way, 2 of them phase 3. Of 7 finished, 0 (0%) have results posted.
Among the 14 studies in Renal Insufficiency, Chronic by University Medical Center Groningen, this one is the 9th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2025, is one of 3 in phase 2, and was the 14th registered.
University Medical Center Groningen’s Renal Insufficiency, Chronic studies by the year they started, since 2014.
6 of the studies testing finerenone in Renal Insufficiency, Chronic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT07235891Alexandria UniversityRetinal Protective Effects of Novel Finerenone in Patients With Chronic Kidney Disease | 2026-12-20 |
| NCT07026539University of AarhusEffect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes. | 2026-12-31 |
| NCT07849348Peking University People's HospitalStudy on the Efficacy and Safety of Initial Combination of Finerenone and Semaglutide in Non-Diabetic Adult Patients With Obesity Complicated by Chronic Kidney Disease With Albuminuria | 2027-02 |
| NCT07155694Washington D.C. Veterans Affairs Medical CenterRole of Finerenone in African American Veterans With Diabetic Kidney Disease | 2027-07 |
Add all 6 to your calendar (.ics) → With an account.
Among the 25 studies testing finerenone in Renal Insufficiency, Chronic, from their registry updates:
Among University Medical Center Groningen’s 14 in Renal Insufficiency, Chronic:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The FINESSE-CKD trial investigates a personalized approach to the treatment of chronic kidney disease (CKD) by comparing the effects of finerenone and semaglutide on albuminuria. Approximately 36 participants will receive both treatments in a randomized crossover design, with the aim of identifying which treatment provides the greatest individual reduction in albuminuria. The primary objective is to determine whether a reduction of at least 30% in albuminuria can be achieved. The study will also assess the effect of combining both treatments and the feasibility of remotely monitoring treatment response through home measurements and urine collections. The total study duration is approximately 40 weeks.
The FINESSE-CKD trial investigates whether treatment for chronic kidney disease (CKD) can be personalized based on an individual patient's response to finerenone and semaglutide. Although both treatments have been shown to reduce albuminuria and improve kidney and cardiovascular outcomes in relevant patient populations, treatment response can vary considerably between individuals. The study therefore aims to identify whether selecting the treatment that provides the greatest reduction in albuminuria for each individual patient can achieve a clinically relevant reduction of at least 30% in urinary albumin-to-creatinine ratio (UACR).
This is a randomized, open-label, crossover, multicenter, decentralized clinical trial. Participants will receive finerenone and semaglutide according to the study treatment schedule, allowing the response to each treatment to be assessed within the same individual. The study will also evaluate whether combined treatment with finerenone and semaglutide provides additional albuminuria lowering compared with the individually selected treatment.
A decentralized approach will be used to reduce the need for hospital visits and assess the feasibility of monitoring treatment response remotely. Participants will perform selected measurements and urine collections at home, including monitoring of body weight and blood pressure.
The primary outcome is the proportion of participants achieving a ≥30% reduction in UACR. Secondary outcomes include the percentage change in UACR from baseline and the feasibility of remote urine collection. The study is expected to provide insight into whether an individualized treatment strategy can improve the effectiveness of albuminuria-lowering therapy while reducing unnecessary treatment and patient burden.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
Women of (WOCBP):15
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 weeks finerenone monotherapy → 6-week wash-out → 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out.
Drug: Finerenone (BAY 94-8862) · Drug: Semaglutide 14 MG [Rybelsus] · Drug: Finerenone and Semaglutide
12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out → 6 weeks finerenone monotherapy → 6-week wash-out.
Drug: Finerenone (BAY 94-8862) · Drug: Semaglutide 14 MG [Rybelsus] · Drug: Finerenone and Semaglutide
The dose of oral finerenone is 20 mg/day (up-titrate from 10 mg/day in patients with an eGFR \<60 mL/min/1.73m2 (up-titrate from 10 mg/day in patients with an eGFR \<60 mL/min/1.73m2). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. oral film-coated tablet.
14 mg once daily (registered maximum dose, up-titrate from 3 mg and 7 mg once daily). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. Oral tablet.
Drug pages: Finerenone · Semaglutide
After 4 weeks of maximum tolerated semaglutide, participants will receive combined oral finerenone and semaglutide for 6 weeks. The procedures during the 6 weeks treatment period are the same as those during the finerenone only treatment periods. Because the combination treatment period immediately follows the semaglutide monotherapy treatment period, no additional titration of semaglutide is necessary. During the combination treatment period, the dose of finerenone will be uptitrated after 2 weeks in patients with eGFR ≥60 mL/min/1.73m2 and serum potassium ≤5.0 mmol/L.
Proportion of patients with ≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during monotherapy with finerenone or semaglutide or combined treatment with finerenone-semaglutide.
Time frame: From baseline to the end of study (Week 37)
Percentage change in UACR
Time frame: From baseline to end of study (week 37)
Number of missed urine collection in the remote (@home) setting
Time frame: From baseline to end of study (Week 37)
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2025 to primary completion in Aug 2026, 18 months.
Of 59 non-industry phase 2 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 62. This study's 18 months is below that.
Counting every sponsor, half of 139 studies reached it within 25 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Finerenone · Semaglutide
Renal Insufficiency, Chronic →
University Medical Center Groningen →